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Brief Online Interventions for Alcohol Use

Brief Online Interventions for Alcohol Use: A Crowdsourced Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03438539
Enrollment
444
Registered
2018-02-19
Start date
2018-02-22
Completion date
2018-07-27
Last updated
2020-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Brief summary

The purpose of this study is to test the feasibility and acceptability of delivering cognitive training over mTurk. Subjects will be randomized to a 1) inhibitory control training condition, 2) working memory training condition, or 3) control training condition. Recent studies have also demonstrated the feasibility and potential efficacy of delivering brief normative feedback to reduce alcohol consumption through mTurk. In these brief interventions, subjects are provided information about their drinking compared to their same age and gendered peers. Approximately half of the subjects in each cognitive training group will receive normative feedback to evaluate effects on alcohol consumption and possible interactions with cognitive training. This study will focus on alcohol use given the ease and clinical acceptance of alcohol use self-report as a primary outcome.

Detailed description

Alcohol use disorder is a persistent public health concern. Approximately 16 million Americans met criteria for alcohol use disorder in 2015, with the annual economic impact of excessive drinking estimated at $250 billion. Alcohol use can also interact with other licit (e.g., cigarettes) and illicit (e.g., cocaine) substances to increase health risks . At least half of all violent crimes involve alcohol consumption and problem drinking plays an important role in domestic abuse and intimate partner violence . These evident economic, health, and social implications of alcohol misuse highlight the importance of understanding determinants of alcohol use behaviors and developing interventions designed to address maladaptive patterns of use. Cognitive training to address alcohol and other substance use disorders has received a great deal of attention in the interventions development literature. Training may be broadly divided into two classes: 1) cognitive bias modification and response inhibition (i.e., inhibitory control) and 2) working memory interventions. Inhibitory control training attempts to retrain prepotent responses away from drug-related cues by specifically pairing those cues with no-go signals in training tasks. Working memory training uses cognitive-behavioral tasks (e.g., letter/digit strings, visual search, n-back) to improve information maintenance and manipulation. These brief interventions hold particular appeal because they may be easily incorporated into comprehensive approaches to substance use treatment. For example, cognitive improvements due to brief training may improve engagement with and attention to cognitive-behavioral therapy and compliance with homework and other program-related activities. Generally speaking, training has consistently demonstrated improvements on the trained or similar tasks as well as related concepts (e.g., delay discounting is improved after working memory training). Improvements in dissimilar tasks or different domains are not consistently observed, however, and clinical measures, such as drug use, have seen mixed outcomes. A significant limitation of the extant literature is the relatively small samples typically evaluated (i.e., 20-40 subjects per condition). It is likely that the effects of cognitive training are of a small-to-medium effect size, however, the relatively low costs of training procedures mean that small effect sizes may not preclude clinical utility. It is also likely that individual characteristics will moderate the utility of these interventions for impacting substance use or related negative health behaviors. The use of small samples precludes testing these types of moderators with adequate statistical power as does the recruitment of comparably homogeneous samples (e.g., student samples, individuals from a single addiction clinic). An emerging method addressing these concerns is crowdsourcing. Crowdsourcing, such as on Amazon.com's Mechanical Turk (mTurk), allows for the effective and efficient sampling of diverse subjects. We have previously demonstrated a close correspondence between in-person and online findings using mTurk in substance use research providing support for the validity of the resource. We have also recently demonstrated feasibility, acceptability, and validity of conducting intensive longitudinal research related to substance use on this platform. Demonstrating the feasibility and acceptability of applying cognitive training methods through mTurk would help establish this setting for future large sample studies testing novel interventions and/or individual characteristic moderating intervention efficacy. The purpose of this study is to test the feasibility and acceptability of delivering cognitive training over mTurk. Subjects will be randomized to a 1) inhibitory control training condition, 2) working memory training condition, or 3) control training condition. Recent studies have also demonstrated the feasibility and potential efficacy of delivering brief normative feedback to reduce alcohol consumption through mTurk. In these brief interventions, subjects are provided information about their drinking compared to their same age and gendered peers. Approximately half of the subjects in each cognitive training group will receive normative feedback to evaluate effects on alcohol consumption and possible interactions with cognitive training. This study will focus on alcohol use given the ease and clinical acceptance of alcohol use self-report as a primary outcome.

Interventions

BEHAVIORALNormative Feedback

Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.

The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.

BEHAVIORALWorking Memory Training

A battery of working memory tasks will be used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks will include visuospatial working memory task, digit span task, letter span task, and the n-back task.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Craig Rush
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

An Internet survey hosted by Amazon.com's Mechanical Turk and Qualtrics: Online Survey Software will be used in this protocol. Cognitive tasks will be coded using PsyToolKit, an open-source tool for programming and running cognitive-psychological experiments and surveys online (Stoet, 2017). A mixed-model design will be used such that subjects are randomly assigned to one of three cognitive training conditions and two information feedback conditions (i.e., between-subjects variables). The same subjects will be sampled at each time point in the study (i.e., repeated/longitudinal variables).

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Self-reported past week alcohol use. * Meet criteria for Alcohol Use Disorder (AUD), verified by computerized questionnaire for DSM-V AUD criteria (Appendix A). * Age 21 years or older. * Express interest in completing a 2-week study involving daily cognitive tasks. * Residence in the United States

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Alcohol UsePast two weeksSelf-report of percent of heavy alcohol drinking days

Secondary

MeasureTime frameDescription
Percentage of Sessions Completed (Feasibility)2 weeksCompletion rates during intervention period
Treatment Acceptability Questionnaire2 weeksTotal average ratings on a treatment acceptability questionnaire, rated from 0 (minimum) to 100 (maximum). Higher scores indicate greater treatment acceptability.

Countries

United States

Participant flow

Participants by arm

ArmCount
Attentional Control With Normative Feedback
Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.
76
Inhibitory Control Training With Normative Feedback
The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Normative Feedback: Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender. Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.
72
Working Memory Training With Normative Feedback
A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to normative feedback were directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.
76
Attentional Control Without Normative Feedback
Control training tasks included completion of basic arithmetic problems for approximately 5 minutes. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013).
73
Inhibitory Control Training Without Normative Feedback
The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Inhibitory Control Training: The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.
73
Working Memory Training Without Normative Feedback
A battery of working memory tasks was used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks included visuospatial working memory task, digit span task, letter span task, and the n-back task. Subjects assigned to not receive normative feedback received feedback on time spent doing a non-alcohol related activity as an attention/informational control (e.g., time spent watching television; LaBrie et al., 2013). Working Memory Training: A battery of working memory tasks will be used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks will include visuospatial working memory task, digit span task, letter span task, and the n-back task.
74
Total444

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyLost to Follow-up8410938

Baseline characteristics

CharacteristicInhibitory Control Training With Normative FeedbackWorking Memory Training With Normative FeedbackAttentional Control With Normative FeedbackAttentional Control Without Normative FeedbackInhibitory Control Training Without Normative FeedbackWorking Memory Training Without Normative FeedbackTotal
Age, Continuous32.5 years
STANDARD_DEVIATION 9.3
35.2 years
STANDARD_DEVIATION 9.5
34.1 years
STANDARD_DEVIATION 8.7
35.8 years
STANDARD_DEVIATION 11
34.3 years
STANDARD_DEVIATION 10.9
33.7 years
STANDARD_DEVIATION 8.5
34.3 years
STANDARD_DEVIATION 9.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
6 Participants6 Participants5 Participants5 Participants1 Participants3 Participants26 Participants
Race (NIH/OMB)
Black or African American
3 Participants6 Participants5 Participants4 Participants5 Participants5 Participants28 Participants
Race (NIH/OMB)
More than one race
4 Participants0 Participants3 Participants3 Participants0 Participants2 Participants12 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants1 Participants0 Participants1 Participants0 Participants4 Participants
Race (NIH/OMB)
White
59 Participants62 Participants62 Participants61 Participants66 Participants64 Participants374 Participants
Region of Enrollment
United States
72 participants76 participants76 participants73 participants73 participants74 participants444 participants
Sex: Female, Male
Female
40 Participants41 Participants39 Participants41 Participants36 Participants30 Participants227 Participants
Sex: Female, Male
Male
32 Participants35 Participants37 Participants32 Participants37 Participants44 Participants217 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 760 / 720 / 760 / 730 / 730 / 74
other
Total, other adverse events
0 / 760 / 720 / 760 / 730 / 730 / 74
serious
Total, serious adverse events
0 / 760 / 720 / 760 / 730 / 730 / 74

Outcome results

Primary

Alcohol Use

Self-report of percent of heavy alcohol drinking days

Time frame: Past two weeks

Population: These data include only participants that were randomized and completed the follow-up assessment providing valid alcohol use data.

ArmMeasureValue (MEAN)Dispersion
Attentional Control With Normative FeedbackAlcohol Use19.4 percentage heavy drinking daysStandard Deviation 30.3
Inhibitory Control Training With Normative FeedbackAlcohol Use16.3 percentage heavy drinking daysStandard Deviation 29.4
Working Memory Training With Normative FeedbackAlcohol Use15.3 percentage heavy drinking daysStandard Deviation 25
Attentional Control Without Normative FeedbackAlcohol Use19.1 percentage heavy drinking daysStandard Deviation 29.7
Inhibitory Control Training Without Normative FeedbackAlcohol Use19.6 percentage heavy drinking daysStandard Deviation 26.7
Working Memory Training Without Normative FeedbackAlcohol Use21.0 percentage heavy drinking daysStandard Deviation 30.7
Secondary

Percentage of Sessions Completed (Feasibility)

Completion rates during intervention period

Time frame: 2 weeks

ArmMeasureValue (MEAN)Dispersion
Attentional Control With Normative FeedbackPercentage of Sessions Completed (Feasibility)68.6 percentage of sessions completedStandard Deviation 35.1
Inhibitory Control Training With Normative FeedbackPercentage of Sessions Completed (Feasibility)63.3 percentage of sessions completedStandard Deviation 35.5
Working Memory Training With Normative FeedbackPercentage of Sessions Completed (Feasibility)56.5 percentage of sessions completedStandard Deviation 39
Attentional Control Without Normative FeedbackPercentage of Sessions Completed (Feasibility)66.1 percentage of sessions completedStandard Deviation 35.3
Inhibitory Control Training Without Normative FeedbackPercentage of Sessions Completed (Feasibility)74.7 percentage of sessions completedStandard Deviation 32.6
Working Memory Training Without Normative FeedbackPercentage of Sessions Completed (Feasibility)59.9 percentage of sessions completedStandard Deviation 37
Secondary

Treatment Acceptability Questionnaire

Total average ratings on a treatment acceptability questionnaire, rated from 0 (minimum) to 100 (maximum). Higher scores indicate greater treatment acceptability.

Time frame: 2 weeks

Population: These data include only participants that were randomized and completed the follow-up assessment providing valid acceptability data.

ArmMeasureValue (MEAN)Dispersion
Attentional Control With Normative FeedbackTreatment Acceptability Questionnaire80.8 units on a scaleStandard Deviation 18.3
Inhibitory Control Training With Normative FeedbackTreatment Acceptability Questionnaire75.9 units on a scaleStandard Deviation 21.4
Working Memory Training With Normative FeedbackTreatment Acceptability Questionnaire77.9 units on a scaleStandard Deviation 20.9
Attentional Control Without Normative FeedbackTreatment Acceptability Questionnaire84.2 units on a scaleStandard Deviation 19.3
Inhibitory Control Training Without Normative FeedbackTreatment Acceptability Questionnaire81.9 units on a scaleStandard Deviation 17.3
Working Memory Training Without Normative FeedbackTreatment Acceptability Questionnaire74.6 units on a scaleStandard Deviation 19

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026